NCT07113223Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms: a Pragmatic Randomized Clinical Trial (DECISION)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The DECISION trial aims to evaluate the efficacy of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk. This multicenter, pragmatic, randomized clinical trial involves two groups: patients receiving AI-assisted ECG analysis and those undergoing standard ECG evaluation. The study's primary analysis will compare the diagnostic performance of AI-assisted ECG versus standard ECG using sensitivity, specificity, and predictive value metrics. Secondary analyses will evaluate healthcare resource utilization, clinical outcomes, and usability feedback from healthcare providers. Results will inform the potential integration of AI-assisted ECG in routine primary care workflows for earlier HF detection and better resource allocation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1968 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 23 Jul 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Idoven 1903 S.L.
- Diseases
- Heart failure
- NCT number
- NCT07113223
What you commit to
- Study type: Interventional
- Planned participants: 1968
- From 23 Jul 2025 to the primary completion date, 31 Mar 2027
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Heart Failure diagnosis.
Other
- Unwillingness or inability to sign the written informed consent.
- Unavailability or suboptimal quality ECG.
Who the study is looking for
- Patients with Suspected HF (Group S):
- Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative).
- Age over 65 years (i.e., 65 included).
- Presence of symptoms and/or signs typical of Heart Failure (defined by the European Society of Cardiology, ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations.
- Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R):
- Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative).
- Age over 65 years (i.e., 65 included).
- Absence of symptoms and/or signs typical of Heart Failure (defined by the ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations.
- Presence of at least 1 ACC/AHA Heart Failure risk factor, including hypertension, cardiovascular disease (atrial fibrillation, coronary heart disease or stroke), diabetes, obesity, exposure to cardiotoxic agents, genetic variant for cardiomyopathy, or family history of cardiomyopathy that requires an ECG test for any reason in a primary care center or with an indication of a regular health examination where an ECG is included.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Primary Care: Gerencia Asistencial Atención Primaria Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Region Stockholm Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.